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Recall Observatory FDA recall evidence

Device product

miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

Z-0234-2016

October 09, 2015

Class II

Product summary

Firm
Miramar Labs, Inc.
Event
Event 72386
Status
Terminated
Classification
Class II
Quantity
277 units
Official record key
device-enforcement:Z-0234-2016

Official wording

Reason: Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.

Code information: MN-MD4000-MC, all units

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.